AGGRENOX is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis (1)
DOSAGE AND ADMINISTRATION

• One capsule twice daily (morning and evening) with or without food (2)
• In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning; resume BID dosing within one week (2)
• Do not chew capsule (2)
• Not interchangeable with the individual components of aspirin and dipyridamole tablets (2)
• Dispense in this unit-of-use container (16)

• Hypersensitivity to any product ingredients (4.1)
• Patients with known allergy to NSAIDs (4.2)
• Patients with the syndrome of asthma, rhinitis, and nasal polyps (4.2)

• The risk of GI bleeding is increased, especially in patients who are heavy alcohol users, have a history of peptic ulcer, or have coagulation abnormalities due to liver disease or vitamin K deficiency (5.1)
• As with other antiplatelets, there is a risk of intracranial hemorrhage (5.1)
• Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3)
• Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4)

• The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea (6)

To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Co-administration with anti-coagulants or NSAIDS can increase risk of bleeding (7.4, 7.10)
• Decreased renal function can occur with co-administration with NSAIDS (7.10)

• Pregnancy Category D (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling